Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-25 @ 4:29 AM
NCT ID:
NCT01825720
Eligibility Criteria:
Inclusion Criteria:
* patients(20 yr or older) undergoing elective valvular heart surgery under cardiopulmonary bypass(CPB) with more than 2 of following features:
1. congestive heart failure
2. infective endocarditis
3. redo valvular surgery
4. surgery combined with coronary bypass graft
5. multiple valvular surgery
6. expected CPB duration longer than 2 hr 7\> preoperative serum creatinine over 1.4 mg/dl 8\> preoperative hemoglobin level less than 12 mg/dl 9\> left ventricular ejection fraction less than 40%
Exclusion Criteria:
1. emergency surgery
2. hemodynamic instability before surgery (mean arterial pressure \< 60 mmHg, heart rate \>100 /min
3. need for pharmacological or mechanical assist for hemodynamic stability before surgery
4. baseline blood lactate level more than 2 mmol/l
5. on steroid or NSAID
6. hepatic dysfunction
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
80 Years
Study:
NCT01825720
Study Brief:
Protocol Section:
NCT01825720